Results 91 to 100 of about 101,010 (263)

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

First‐in‐human, phase I, randomized, safety, pharmacokinetic, food‐effect and pharmacodynamic study of a tyrosine kinase 2/Janus kinase 1 inhibitor, SDC‐1801

British Journal of Clinical Pharmacology, EarlyView.
Aim The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), food‐effect (FE) and pharmacodynamics (PD) of an oral tyrosine kinase‐2 (TYK2)/Janus kinase‐1 (JAK1) inhibitor, SDC‐1801, in healthy adult participants. Methods This first‐in‐human study randomized 95 male and female participants.
Chris Brearley, Sam Francis, John Reader, Judi Proctor   +3 more
wiley   +1 more source

Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post‐authorization studies, 2022–2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Risk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre‐specifying the targets, or ‘thresholds’, for assessing RMM effectiveness. We aimed to review recent industry‐sponsored post‐authorization safety studies (PASS) that evaluated the effectiveness of RMMs ...
Kexin Zhu, William A. Blumentals, Froilan G. Celzo, G. Caleb Alexander, Lingyun Zhou, Juhaeri Juhaeri, Corinne Jouquelet‐Royer, Jian‐Yu E   +7 more
wiley   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Listening to Hong Kong children's perspectives through pretend play

British Educational Research Journal, EarlyView.
Abstract Quality in early childhood education and care (ECEC) has become an increasing concern in recent years. The issue has been regularly discussed by different stakeholders. However, the rising concern regarding quality in ECEC has not seriously taken into account children's perspectives.
Suzannie K. Y. Leung
wiley   +1 more source

Predictors of authorised, unauthorised and persistent absence among secondary school pupils in Scotland

British Educational Research Journal, EarlyView.
Abstract This article examines the factors associated with persistent absenteeism (an absence rate of 10% or higher) and authorised and unauthorised absence among secondary school pupils in Scotland. Using linked administrative data, the analysis focuses on secondary school stages S1–S6 in three academic years.
Silvia Behrens, Morag Treanor, Patricio Troncoso, Bethany Lee‐Shield, Emma Russell, Lee Williamson, Cecilia Macintyre   +6 more
wiley   +1 more source

Falling pupil numbers and school closures: Setting a research agenda for a new era of precarity

British Educational Research Journal, EarlyView.
Abstract This paper explores the significant phenomenon of decreasing pupil numbers in England due to lower birth rates and the impact of a school closure on a school community. It then discusses how the sociology of education might research this major issue.
Eleanor Fagan, Alice Bradbury
wiley   +1 more source

Toward clone‐on‐a‐chip: Ethical and legal considerations for organ‐on‐a‐chip evolution

BMEMat, EarlyView.
The term “clone‐on‐a‐chip (CoC)” is introduced as a conceptual warning for personalized organ‐on‐a‐chip platforms and not to suggest technological feasibility, where a CoC ethical discussion extends beyond issues arising from the requirements for informed consent, property rights, commercialization efforts, and cell sourcing to include potentially ...
Muhammed Erkan Karabekmez, Aliakbar Ebrahimi, Hamed Ghorbanpoor, Nicole Bassous, Su Ryon Shin, Yu Shrike Zhang, Huseyin Avci   +6 more
wiley   +1 more source

Partners or passengers? Revisiting the association between diatoms and aquatic animals

Biological Reviews, EarlyView.
ABSTRACT Numerous studies have revealed the importance of research on the communities capable of colonizing animal surfaces (epibionts) and the animals on which they live (basibionts). Very few studies have considered epizoic diatoms, and there are gaps and biases in our knowledge, including the choice of basibionts, the methods used, and the habitats ...
Gianluca Vacca, Elisa Falasco, Francesca Bona   +2 more
wiley   +1 more source